Roche
CountryStudyStartUpTeamLeader
Neural analysis suggests this role is
optimal for Senior candidates.
“Country Study Start Up Team Leader at Roche. Skills: Clinical trial start-up, Regulatory submissions, People Leader, Clinical systems. Lead country strategy for study start-up. Drive clinical trial submissions”
What You'll Achieve.
Ensure timely site activation; Deliver innovative medicines to patients faster; Improve trial initiation timelines
Industry & Context.
Analytical prowess to turn data into strategic improvements
What They're Looking For.
Must Have
Proven experience in clinical trial start-up, Regulatory submissions, ICH-GCP, EU CTR, Coaching, Mentoring, Leading high-performing teams, University degree (MD, PhD, MS, or BS), Veeva Vault, CTIS, RIM, Fluency in English
Nice to Have
Postgraduate degree, Fluency in Dutch
What You'll Do.
Lead country strategy for study start-up
Drive clinical trial submissions
Manage regulatory coordination
Serve as People Leader
Provide coaching and support
Architect ICF management
Oversee site documentation
Champion process innovation
Identify automation opportunities
Collaborate with global stakeholders
Manage clinical site budgets
Manage clinical site contracts
How You'll Work.
Team & Collaboration
Collaborate with global stakeholders; Partner with stakeholders; Work with local operational teams; Work with global executive leadership
Communication Scope
Exceptional communication; Influence stakeholders; Partner with stakeholders
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position _**Country Study Start-up Team Leader (cSTL)**_ _Roche Nederland B.V., Woerden_ **The Opportunity** At Roche, we advance science so that we all have more time with the people we love. In our Global Clinical Operations (PDG) team, we are looking for a Country Study Start-up Team Leader (cSTL) to take on a dual-impact role that is vital to our mission. _You will be the driving force behind clinical trial submissions while simultaneously serving as a People Leader (for +\- 30% of your time), guiding a dedicated team to success in our country delivery operations._ In this pivotal role, you will balance strategic oversight of study start-up with hands-on leadership in regulatory submissions and people management. Your work ensures that we deliver innovative medicines to patients faster and more efficiently by streamlining the bridge between clinical design and site activation. **In this role, you will:** * Lead the country strategy for study start-up, driving efficiency and innovation to ensure timely site activation. * Drive clinical trial submissions and regulatory coordination, managing complex submission packages and responding to Health Authority queries. * Serve as a People Leader for approximately 30% of your time, providing coaching, support, and professional development to your direct reports. * Architect and oversee the management of Informed Consent Forms (ICF) and clinical site documentation to ensure global compliance. * Champion process innovation by identifying opportunities for auto
Applying for this Country Study Start Up Team Leader role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Roche?
Real rants from real employees. Read before you apply.